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DARAPRIM Direct

The DARAPRIM Direct Program was created to help patients obtain quick and affordable access to DARAPRIM. From the moment you’ve
prescribed DARAPRIM, dedicated Case Managers can help educate and support your patients through every step.

Financial Assistance

The DARAPRIM Direct Program helps ensure that you have one less concern when it comes to getting your patients started on their
medication. A DARAPRIM Case Manager will work with your patient to understand their insurance coverage, financial needs and the
financial assistance programs that they may be eligible for.¹

¹Financial assistance programs are subject to terms and conditions and patient eligibility requirements. Restrictions, including where prohibited by law, may apply. Offers are subject
to change or discontinuance without notice. Financial assistance programs are not insurance nor are they intended to be a substitute for insurance.

Important Safety Information

INDICATIONS

DARAPRIM® (pyrimethamine) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide.

IMPORTANT SAFETY INFORMATION

DARAPRIM is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation and in patients with documented megaloblastic anemia due to folate deficiency.

Potential for folate deficiency: Dosage required for toxoplasmosis treatment approaches the toxic level. If signs of folate deficiency develop, reduce the dosage or discontinue the drug according to patient response. Administer folinic acid (leucovorin) at 5-15 mg per day until normal hematopoiesis is restored.

Carcinogenic potential: Data indicates that pyrimethamine may be carcinogenic.

There are no adequate and well-controlled studies in pregnant women. DARAPRIM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be warned against becoming pregnant during treatment with DARAPRIM.

Pyrimethamine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pyrimethamine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Keep out of the reach of infants and children: Deaths in pediatric patients have been reported after accidental ingestion.

Drug Interactions:

The concomitant use of pyrimethamine with other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim-sulfamethoxazole combination, proguanil, zidovudine, or cytostatic agents (e.g., methotrexate), may increase the risk of bone marrow suppression. If signs of folate deficiency develop, pyrimethamine should be discontinued and folinic acid should be given until hematopoiesis is restored (see above).

Use DARAPRIM with caution in patients receiving therapy, such as phenytoin, that affect folate levels.

Mild hepatotoxicity can occur when lorazepam and pyrimethamine are administered concomitantly.

Dosing Information:

For specific dosing instructions see the Full Prescribing Information.

Do not exceed the recommended dosage.

Start with a small dose for toxoplasmosis in patients with convulsive disorders to avoid the potential nervous system toxicity of pyrimethamine (see Overdosage).

Use with caution in patients with impaired renal or hepatic function; in patients with possible folate deficiency such as individuals with malabsorption syndrome, alcoholism, or who are pregnant; and in the elderly due to the potential for decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this population.

Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis in ALL patients.

In patients receiving a high dosage, semiweekly blood counts, including platelet counts should be performed.

Taking DARAPRIM with meals may minimize associated anorexia and vomiting.

Overdosage:

Following the ingestion of 300 mg or more of pyrimethamine, gastrointestinal and/or central nervous system signs may be present, including convulsions and death.

There is no specific antidote to acute pyrimethamine poisoning. Symptomatic and supportive measures should be employed. Gastric lavage is recommended and is effective if carried out very soon after drug ingestion. Parenteral diazepam may be used to control convulsions. Folinic acid should be administered within 2 hours of drug ingestion to be most effective in counteracting the effects on the hematopoietic system. Daily monitoring of peripheral blood counts is recommended for up to several weeks until normal hematologic values are restored.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Vyera Pharmaceuticals, LLC at 1-877-258-2033.

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the information provided on this external site. This information may not be approved by the FDA. Please
confirm that you would like to continue.

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You are about to leave www.daraprimdirect.com. You are being redirected to an external site that is not owned,
edited, or updated by Vyera Pharmaceuticals. Vyera Pharmaceuticals does not take ownership for nor endorses
the information provided on this external site. This information may not be approved by the FDA. Please
confirm that you would like to continue.

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You are about to leave www.daraprimdirect.com. You are being redirected to an external site that is not owned,
edited, or updated by Vyera Pharmaceuticals. Vyera Pharmaceuticals does not take ownership for nor endorses
the information provided on this external site. This information may not be approved by the FDA. Please
confirm that you would like to continue.

Important Safety Information and Indication

DARAPRIM® (pyrimethamine) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide.

DARAPRIM is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation and in patients with documented megaloblastic anemia due to folate deficiency. Potential for folate deficiency: Dosage required for toxoplasmosis treatment approaches the toxic level. If signs of folate deficiency develop, reduce the dosage or discontinue the drug according to patient response. Administer folinic acid (leucovorin) at 5-15 mg per day until normal hematopoiesis is restored. Pregnancy Category C: Women of childbearing potential should be warned against becoming pregnant during treatment with DARAPRIM.